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| Name | Class |
|---|---|
| Foundation for Anesthesia Education and Research | OTHER |
| American Society of Anesthesiologists | OTHER |
| Washington University School of Medicine | OTHER |
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Awareness during anesthesia is a problem receiving increased attention by patients, clinicians, and the general public. The incidence of intraoperative awareness has been reported to be between 1-2/1000 cases, but recent data suggest that this may be an overestimate. The Bispectral Index (BIS) Monitor is an electroencephalographic method of assessing depth of anesthesia that has been shown in one study to reduce the incidence of awareness during anesthesia in the high-risk population (Myles et al, 2004). In the study of Myles et al, the number needed to treat (NNT) in order to prevent one case of awareness in the high-risk population was 138, with an associated cost of approximately US$2200. Since the NNT and the associated cost of treatment would be much higher in the general population, the efficacy of the BIS monitor in preventing awareness in all anesthetized patients needs to be clearly established. Furthermore, recent data suggest that the BIS may not be useful in the high-risk population. The investigators propose a prospective, randomized, controlled trial comparing the BIS monitor to electronic alerts based on non-electroencephalographic gauges of anesthetic depth.
Electronic alerts have been developed and employed at our institution and have been shown to increase compliance with both clinical and administrative tasks (O'Reilly et al, 2006; Kheterpal et al, 2007). The investigators have developed electronic alerts for the purpose of informing the clinician of potentially insufficient anesthesia based on minimum alveolar concentration (MAC). The algorithm is as follows:
Every 5 minutes the alerting system checks every active case in our operating rooms. It takes approximately 1 second for this scan of all active cases to occur.
Conditions for an "active case" are:
The alerting system checks the most recent value (within a specified time period) of:
The system then checks for a charted propofol infusion in mcg/kg/min and divides by 150, assuming that 150 mcg/kg/min is "1.0 MAC" for propofol. The analogous concept of MAC for propofol is "Cp50"- the plasma or blood concentrations at which 50% of patients do not move in response to a noxious stimulus. Since the investigators do not have the technology at our institution to calculate Cp50 or Cp50-awake, the investigators have chosen the above propofol dose as an initial value based on clinical experience. The resultant MAC equivalent is added to current total MAC.
The system next checks for a dexmedetomidine infusion with a rate of 0.2 mcg/kg/hour or greater. If present, it multiplies the current total inhalational MAC by 2, as dexmedetomidine can reduce MAC by 50%.
At this point, the "current total MAC" is defined as: Et Sevo /2 + Et Iso /1.2 + Et Des/6 + Et Nitrous /105 + propofol rate (in mcg/kg/min)/150. If dexmedetomidine is >0.2 mcg/kg/hour, inhalational MAC is multiplied by 2.
If this total mac < 0.50, it checks to see if a bolus of propofol, midazolam, etomidate, or thiopental has been given in the preceding 10 minutes.
It alerts the clinician signed into the case within 30-60 seconds if total age-adjusted MAC < 0.50 AND no bolus has been documented in the last 10 minutes.
This will be the protocol in the MAC-guided group. In the BIS-guided group an electronic alert will be sent if the BIS value is >60. If an alert is triggered, the clinician electronically signed into the case receives an alphanumeric page stating "Potentially insufficient anesthesia, please check vaporizers and intravenous lines."
The investigators are collaborating with Washington University, the University of Chicago, and the University of Mannitoba, who will also be testing a MAC-based protocol in comparison to the BIS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIS group | Experimental | This group will have BIS values visible and will receive alerts when the value is >60. |
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| MAC Alert | Active Comparator | This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bispectral Index Monitor | Device | Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups. | By modified intention-to-treat analysis | Outcome of awareness is assessed 30-days after the operation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dreams During Anesthesia Compared Between MAC or BIS Monitoring | Binary variables for whether participants recall dreaming or not. | During surgery (45 minutes - 18 hours), measured based on 30 day interviews |
| Percentage of Cases With Electronic Alerts |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship Between BIS Values and Hemodynamic Parameters. | Outcome of hemodynamic stability is assessed | |
| The Relationship Between Cumulative Deep Hypnotic Time, Anesthetic Doses, and Mortality. | Outcome of mortality is assessed |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George A. Mashour, M.D., Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Medical School, University Hospital | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25249789 | Derived | Vance JL, Shanks AM, Woodrum DT. Intraoperative bispectral index monitoring and time to extubation after cardiac surgery: secondary analysis of a randomized controlled trial. BMC Anesthesiol. 2014 Sep 18;14:79. doi: 10.1186/1471-2253-14-79. eCollection 2014. | |
| 25010744 | Derived | Shanks AM, Avidan MS, Kheterpal S, Tremper KK, Vandervest JC, Cavanaugh JM, Mashour GA. Alerting thresholds for the prevention of intraoperative awareness with explicit recall: a secondary analysis of the Michigan Awareness Control Study. Eur J Anaesthesiol. 2015 May;32(5):346-53. doi: 10.1097/EJA.0000000000000123. |
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22,185 patients were recruited but 584 were excluded after recruitment due to change in anesthetic technique, case cancellation, withdrawal, or death. Therefore, 21,601 patients were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bispectral Index Group | This group will have BIS values visible and will receive alerts when the value is >60. Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols. |
| FG001 | Minimum Anesthesia Contration Alert |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| University of Chicago |
| OTHER |
| University of Manitoba | OTHER |
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| Electronic MAC alert | Device | Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols. |
|
| During surgery: (45 minutes - 18 hours) |
| Overall Use of Anesthetics Comparing the BIS to MAC Alerts. | During surgery (45 minutes - 18 hours) |
| Time Till Discharge Readiness | measured in time within Post Anesthesia Care Unit ( PACU) until the participant is ready for discharge from PACU based on a composite of factors, including pain and neurologic status | During recovery room stay: 30 minutes to 6 hours |
| Number of Participants Without Nausea or Vomiting | During recovery room stay: 30 minutes to 6 hours |
| Comparison of the Prospective and Retrospective Approaches to the Study Awareness Incidence. | There is controversy regarding the appropriate technique for assessing awareness during anesthesia with explicit recall. A total cohort was utilized to compare the incidence of awareness with recall as determined by formal interview vs. the incidence of awareness with recall based on spontaneous reports (in the same cohort). | 30 days after surgery |
| Predictors of Post-traumatic Stress Disorder Based on the Type of Awareness Event. | Outcome of post-traumatic stress disorder is assessed with the covariate of awareness |
| Anesthetic Induction Doses, Hypotension, and BIS Values. | Outcome of hypotension in relationship to induction doses and BIS values will be assessed |
| Meta-Analysis of Awareness Events in Conjunction With the BAG-RECALL Study Based at Washington University. | Outcome of awareness is assessed |
| Incidence of Post-traumatic Stress Disorder. | NEED VALUE HERE |
| 19948045 | Derived | Avidan MS, Palanca BJ, Glick D, Jacobsohn E, Villafranca A, O'Connor M, Mashour GA; BAG-RECALL Study Group. Protocol for the BAG-RECALL clinical trial: a prospective, multi-center, randomized, controlled trial to determine whether a bispectral index-guided protocol is superior to an anesthesia gas-guided protocol in reducing intraoperative awareness with explicit recall in high risk surgical patients. BMC Anesthesiol. 2009 Nov 30;9:8. doi: 10.1186/1471-2253-9-8. |
| 19891771 | Derived | Mashour GA, Tremper KK, Avidan MS. Protocol for the "Michigan Awareness Control Study": A prospective, randomized, controlled trial comparing electronic alerts based on bispectral index monitoring or minimum alveolar concentration for the prevention of intraoperative awareness. BMC Anesthesiol. 2009 Nov 5;9:7. doi: 10.1186/1471-2253-9-7. |
This group will receive an alert if total MAC (Minimum Anesthesia Concenration) (including intravenous infusions) is <0.5 age-adjusted. Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bispectral Index Group | This group will have BIS values visible and will receive alerts when the value is >60. Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols. |
| BG001 | Minimum Anesthesia Concentration Alert | This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted. Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
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| Primary | The Percentage of Incidences With Explicit Recall in the BIS Versus MAC Alert Groups. | By modified intention-to-treat analysis | Posted | Number | 95% Confidence Interval | Percentage of participants/30days | Outcome of awareness is assessed 30-days after the operation |
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| Secondary | Number of Participants With Dreams During Anesthesia Compared Between MAC or BIS Monitoring | Binary variables for whether participants recall dreaming or not. | Posted | Count of Participants | Participants | During surgery (45 minutes - 18 hours), measured based on 30 day interviews |
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| Secondary | Percentage of Cases With Electronic Alerts | Posted | Mean | Standard Deviation | Percentage of cases | During surgery: (45 minutes - 18 hours) |
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| Secondary | Overall Use of Anesthetics Comparing the BIS to MAC Alerts. | Posted | Median | Inter-Quartile Range | mg | During surgery (45 minutes - 18 hours) |
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| Secondary | Time Till Discharge Readiness | measured in time within Post Anesthesia Care Unit ( PACU) until the participant is ready for discharge from PACU based on a composite of factors, including pain and neurologic status | Posted | Median | Inter-Quartile Range | minutes | During recovery room stay: 30 minutes to 6 hours |
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| Secondary | Number of Participants Without Nausea or Vomiting | Nausea and vomiting numbers were dependent on nurse reporting; as not all nurses did, the participants analyzed are fewer than the total number in the study. | Posted | Count of Participants | Participants | During recovery room stay: 30 minutes to 6 hours |
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| Secondary | Comparison of the Prospective and Retrospective Approaches to the Study Awareness Incidence. | There is controversy regarding the appropriate technique for assessing awareness during anesthesia with explicit recall. A total cohort was utilized to compare the incidence of awareness with recall as determined by formal interview vs. the incidence of awareness with recall based on spontaneous reports (in the same cohort). | Posted | Number | participants | 30 days after surgery |
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| Other Pre-specified | Relationship Between BIS Values and Hemodynamic Parameters. | Not Posted | Outcome of hemodynamic stability is assessed | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | The Relationship Between Cumulative Deep Hypnotic Time, Anesthetic Doses, and Mortality. | Not Posted | Outcome of mortality is assessed | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Predictors of Post-traumatic Stress Disorder Based on the Type of Awareness Event. | Not Posted | Outcome of post-traumatic stress disorder is assessed with the covariate of awareness | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Anesthetic Induction Doses, Hypotension, and BIS Values. | Not Posted | Outcome of hypotension in relationship to induction doses and BIS values will be assessed | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Meta-Analysis of Awareness Events in Conjunction With the BAG-RECALL Study Based at Washington University. | Not Posted | Outcome of awareness is assessed | Participants | |||||||||||||||||||||||||||||||||||
| Other Pre-specified | Incidence of Post-traumatic Stress Disorder. | Not Posted | NEED VALUE HERE | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bispectral Index Group | This group will have BIS values visible and will receive alerts when the value is >60. Bispectral Index Monitor: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols. | 0 | 9,460 | 0 | 9,460 | ||
| EG001 | Miniumum Anesthesia Concentration Alert | This group will receive an alert if total MAC (including intravenous infusions) is <0.5 age-adjusted. Electronic MAC alert: Comparison of two different alerting protocols. One using the bispectral index monitor and one using the MAC alerting protocols. | 0 | 9,376 | 0 | 9,376 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non life threatening adverse events | Cardiac disorders | No adverse events resulted from this study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. George A Mashour | University of Michigan | 734-936-4280 | gmashour@med.umich.edu |
| ID | Term |
|---|---|
| D056805 | Consciousness Monitors |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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